{"id":41337,"date":"2016-08-30T19:40:03","date_gmt":"2016-08-30T23:40:03","guid":{"rendered":"https:\/\/regstaging.wpengine.com\/fda-drugs\/"},"modified":"2020-02-21T16:41:59","modified_gmt":"2020-02-21T16:41:59","slug":"fda-drugs","status":"publish","type":"page","link":"https:\/\/legacy.registrarcorp.com\/de\/fda-drugs\/","title":{"rendered":"Arzneimittel"},"content":{"rendered":"
[vc_section el_id=”pageHero” css=”.vc_custom_1581876736941{background-image: url(https:\/\/regstaging.wpengine.com\/wp-content\/uploads\/2020\/02\/drug-hero-1.jpg?id=41267) !important;background-position: center !important;background-repeat: no-repeat !important;background-size: cover !important;}” el_class=”page-solutions”][vc_row el_class=”page-marquee”][vc_column][vc_column_text el_class=”half-width”]\n

Arzneimittel<\/h1>\n
\n

Registrieren Sie sich bei der U.S. Food and Drug Administration (FDA)<\/strong><\/h2>\n[\/vc_column_text][vc_row_inner el_class=”row-content-center”][vc_column_inner]
Beginnen<\/span><\/div>
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Registrierung
\nund Auflistung<\/h2>\n[\/vc_column_text][\/vc_column][vc_column width=”1\/2″ el_class=”side-right align-left”][vc_column_text el_class=”side-text-block”]Eigent\u00fcmer oder Betreiber aller US und Nicht-US Arzneimitteleinrichtungen, die sich mit der Herstellung, Zubereitung, Vermehrung, Zusammenst\u00e4llung, Aufbereitung oder Verarbeitung von Arzneimitteln befassen, m\u00fcssen eine Liste aller in den Vereinigten Staaten im Handel vertriebenen Arzneimittel registrieren und einreichen.[\/vc_column_text][vc_column_text el_class=”side-links”]Beginnen<\/a><\/p>\n

Preisgestaltung<\/a>[\/vc_column_text][\/vc_column][\/vc_row][vc_row el_class=”side-by-side mobile-reverse”][vc_column width=”1\/2″ el_class=”side-left align-left” css=”.vc_custom_1581877147665{background-color: #3b4254 !important;background-position: center !important;background-repeat: no-repeat !important;background-size: cover !important;}”][vc_column_text el_class=”side-text-block font-white”]Die FDA schreibt vor, dass Arzneimitteletiketten mithilfe der Extensible Markup Language (XML) im SPL-Format (Structured Product Labelling) indiziert werden. Registrar Corp kann helfen, Ihre Arzneimittelkennzeichnung zu modifizieren, um den FDA-Vorschriften zu entsprechen. Registrar Corp stellt \u00fcberarbeitete Grafikdateien bereit, die gedruckt oder bearbeitet werden k\u00f6nnen, und einen Bericht, der die Vorschriften, Compliance-Richtlinien, Warnhinweise, Importwarnungen und andere Leitf\u00e4den der FDA beschreibt.[\/vc_column_text][vc_column_text el_class=”side-links font-white”]Beginnen<\/a><\/p>\n

Preisgestaltung<\/a>[\/vc_column_text][\/vc_column][vc_column width=”1\/2″ el_class=”side-right align-left hasImage” css=”.vc_custom_1581877157753{background-image: url(https:\/\/regstaging.wpengine.com\/wp-content\/uploads\/2020\/02\/drug-label-scaled.jpg?id=41281) !important;background-position: center !important;background-repeat: no-repeat !important;background-size: cover !important;}”][vc_column_text el_class=”side-title-block”]\n

Etikettierung und
\nInhaltsstoff-\u00dcberpr\u00fcfung<\/h2>\n[\/vc_column_text][\/vc_column][\/vc_row][vc_row el_class=”side-by-side”][vc_column width=”1\/2″ el_class=”side-left align-right hasImage” css=”.vc_custom_1581877512373{background-image: url(https:\/\/regstaging.wpengine.com\/wp-content\/uploads\/2018\/03\/fda-drug-master.jpg?id=40102) !important;background-position: center !important;background-repeat: no-repeat !important;background-size: cover !important;}”][vc_column_text el_class=”side-title-block”]\n

Drug Master
\nFiles<\/h2>\n[\/vc_column_text][\/vc_column][vc_column width=”1\/2″ el_class=”side-right align-left”][vc_column_text el_class=”side-text-block”]Eine Drug Master File (DMF) ist eine Einreichung bei der FDA, die zur Unterst\u00fctzung von Premarket-Einreichungen verwendet werden kann, um vertrauliche, detaillierte Informationen \u00fcber Einrichtungen, Prozesse oder Artikel bereitzustellen, die bei der Herstellung, Verarbeitung, Verpackung oder Lagerung eines oder mehrerer Arzneimittel verwendet werden. Registrar Corps Spezialisten bieten Anleitungen zu den erforderlichen Elementen, Formaten und Besonderheiten der Einreichung von Drug Master Files.[\/vc_column_text][vc_column_text el_class=”side-links”]Beginnen<\/a><\/p>\n

Preisgestaltung<\/a>[\/vc_column_text][\/vc_column][\/vc_row][\/vc_section][vc_section css=”.vc_custom_1574176315943{background-color: #ececec !important;}”][vc_row equal_height=”yes” el_class=”grid-tiles”][vc_column width=”1\/2″ offset=”vc_col-lg-4 vc_col-md-6 vc_col-xs-12″][vc_column_text css=”.vc_custom_1581877433799{background-image: url(https:\/\/regstaging.wpengine.com\/wp-content\/uploads\/2020\/02\/adverse-event-scaled.jpg?id=41239) !important;}” el_class=”grid-tile-title hasImage”]\n

Adverse Event Contact for OTC Drugs<\/h2>\n[\/vc_column_text][vc_column_text el_class=”grid-tile-block”]U.S. FDA requires labels of OTC drugs marketed without an approved application to bear a United States address or phone number to receive consumer reports of serious adverse events. Registrar Corp can serve as your U.S. Contact for the timely forwarding of consumer reports to your business as required by FDA.[\/vc_column_text][vc_column_text el_class=”grid-tile-links”]Get Started<\/a><\/p>\n

View Pricing<\/a>[\/vc_column_text][\/vc_column][vc_column width=”1\/2″ offset=”vc_col-lg-4 vc_col-md-6 vc_col-xs-12″][vc_column_text css=”.vc_custom_1581963084377{background-image: url(https:\/\/regstaging.wpengine.com\/wp-content\/uploads\/2018\/08\/drug-labels-new-product.jpg?id=40003) !important;}” el_class=”grid-tile-title hasImage”]\n

Vorschriften f\u00fcr die FDA-Outsourcing-Einrichtung<\/h2>\n[\/vc_column_text][vc_column_text el_class=”grid-tile-block”]Compounding-Apotheken, die sich bei der FDA als Outsourcing-Einrichtungen registrieren, k\u00f6nnen m\u00f6glicherweise von bestimmten FDA-Genehmigungs- und Kennzeichnungsanforderungen befreit werden. Die Spezialisten von Registrar Corp k\u00f6nnen Apotheken als Outsourcing-Einrichtungen registrieren und ihnen dabei helfen, die Vorschriften der FDA einzuhalten, einschlie\u00dflich der Einreichung j\u00e4hrlicher Arzneimittelproduktberichte.[\/vc_column_text][vc_column_text el_class=”grid-tile-links”]Beginnen<\/a><\/p>\n

Preisgestaltung<\/a>[\/vc_column_text][\/vc_column][vc_column width=”1\/2″ offset=”vc_col-lg-4 vc_col-md-6 vc_col-xs-12″][vc_column_text css=”.vc_custom_1581963168357{background-image: url(https:\/\/regstaging.wpengine.com\/wp-content\/uploads\/2019\/10\/VoluntaryMalfunctionSummary.jpg?id=39819) !important;}” el_class=”grid-tile-title hasImage”]\n

Selbstidentifizierungsanforderungen f\u00fcr Einrichtungen generischer Arzneimittel<\/h2>\n[\/vc_column_text][vc_column_text el_class=”grid-tile-block”]Betreiber von Einrichtungen, die generische Arzneimittel und generische APIs herstellen, m\u00fcssen der FDA zwischen dem 1. Mai und dem 1. Juni eines jeden Jahres \u201cSelbstidentifizierungsinformationen\u201d vorlegen.[\/vc_column_text][vc_column_text el_class=”grid-tile-links”]Beginnen<\/a><\/p>\n

Preisgestaltung<\/a>[\/vc_column_text][\/vc_column][vc_column width=”1\/2″ offset=”vc_col-lg-offset-0 vc_col-lg-4 vc_col-md-offset-0 vc_col-md-6 vc_col-sm-offset-0 vc_col-xs-12″][vc_column_text css=”.vc_custom_1581963396892{background-image: url(https:\/\/regstaging.wpengine.com\/wp-content\/uploads\/2020\/01\/container-yard.png?id=39392) !important;}” el_class=”grid-tile-title hasImage”]\n

3PL\/WDD Berichterstattung<\/h2>\n[\/vc_column_text][vc_column_text el_class=”grid-tile-block”]Die US FDA schreibt vor, dass Drittanbieter (3PL) f\u00fcr Logistik und Arzneimittelgro\u00dfhandels-Vertriebler (WDD) zwischen dem 1. Januar und dem 31. M\u00e4rz jedes Jahres staatliche Zulassung und andere Informationen f\u00fcr alle ihre Einrichtungen melden m\u00fcssen.[\/vc_column_text][vc_column_text el_class=”grid-tile-links”]Beginnen<\/a><\/p>\n

Preisgestaltung<\/a>[\/vc_column_text][\/vc_column][vc_column width=”1\/2″ offset=”vc_col-lg-4 vc_col-md-6 vc_col-xs-12″][vc_column_text css=”.vc_custom_1581963258452{background-image: url(https:\/\/regstaging.wpengine.com\/wp-content\/uploads\/2020\/02\/detention-scaled.jpg?id=41099) !important;}” el_class=”grid-tile-title hasImage”]\n

Hilfe bei Zur\u00fcckhaltung<\/h2>\n[\/vc_column_text][vc_column_text el_class=”grid-tile-block”]Unternehmen, die Produkte in die Vereinigten Staaten versenden, k\u00f6nnen feststellen, dass ihre Sendungen von der FDA der Zur\u00fcckhaltung ohne physische Untersuchung (DWPE) unterliegen. Produkte, die DWPE unterliegen, werden am Einfuhrhafen angehalten, w\u00e4hrend die FDA zus\u00e4tzliche Pr\u00fcfungen, Tests und Analysen durchf\u00fchrt. Verz\u00f6gerungen durch DWPE k\u00f6nnen f\u00fcr Unternehmen, die ihre Produkte termingerecht liefern m\u00f6chten, unagenehm lange dauern.[\/vc_column_text][vc_column_text el_class=”grid-tile-links”]Beginnen<\/a><\/p>\n

Preisgestaltung<\/a>[\/vc_column_text][\/vc_column][vc_column width=”1\/2″ offset=”vc_col-lg-4 vc_col-md-6 vc_col-xs-12″][vc_column_text css=”.vc_custom_1582215228744{background-image: url(https:\/\/regstaging.wpengine.com\/wp-content\/uploads\/2020\/02\/color-additive.jpg?id=41656) !important;}” el_class=”grid-tile-title hasImage”]\n

Anforderungen f\u00fcr Farbadditiv<\/h2>\n[\/vc_column_text][vc_column_text el_class=”grid-tile-block”]Ein Arzneimittelfarbadditiv ist ein jeder Farbstoff, Pigment oder eine andere Substanz, die einem Arzneimittel Farbe verleihen kann. Farbadditive werden von der FDA reguliert.[\/vc_column_text][vc_column_text el_class=”grid-tile-links”]Beginnen<\/a><\/p>\n

Preisgestaltung<\/a>[\/vc_column_text][\/vc_column][vc_column offset=”vc_col-lg-offset-4 vc_col-lg-4 vc_col-md-6 vc_col-xs-12″][vc_column_text css=”.vc_custom_1581963359321{background-image: url(https:\/\/regstaging.wpengine.com\/wp-content\/uploads\/2020\/02\/export-certs-scaled.jpg?id=41085) !important;}” el_class=”grid-tile-title hasImage”]\n

Exportzertifikate an ausl\u00e4ndische Regierungen<\/h2>\n[\/vc_column_text][vc_column_text el_class=”grid-tile-block”]Unternehmen, die Produkte aus den USA exportieren, werden h\u00e4ufig von ausl\u00e4ndischen Kunden oder ausl\u00e4ndischen Regierungen aufgefordert, ein \u201cExport Certificate\u201d f\u00fcr von der FDA regulierte Produkte vorzulegen. Ein Exportzertifikat ist ein von der FDA erstelltes Dokument, das Informationen zum regulatorischen oder Vermarktungs-Status eines Produkts enth\u00e4lt.[\/vc_column_text][vc_column_text el_class=”grid-tile-links”]Beginnen<\/a><\/p>\n

Preisgestaltung<\/a>[\/vc_column_text][\/vc_column][\/vc_row][\/vc_section][vc_row][vc_column]

<\/i><\/i><\/div><\/div><\/div>
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<\/div>[\/vc_column][\/vc_row]\n<\/div>","protected":false},"excerpt":{"rendered":"

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